This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth.

It is used to correct teeth by transmitting physical force to each tooth, and is a selfligation bracket using a ceramic body and a metal cap made of a metal material. Shelf-life is not applicable because of the low likelihood of time-dependent product degradation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Vatech Clismile," which is an orthodontic bracket. The document focuses on demonstrating substantial equivalence to a predicate device, "In-Ovation C." The information does not present a study with detailed acceptance criteria and performance reports in the context of an AI/ML powered device. Instead, it focuses on the equivalence of physical and materials characteristics.

Therefore, many of the requested fields cannot be filled as they pertain to the evaluation of an AI-powered medical device through clinical or performance studies with ground truth establishment, which is not the subject of this document.

However, I can extract the relevant information regarding the technical characteristics and the performance testing mentioned to demonstrate equivalence.

Here's the information based on the provided text, with many fields marked as "Not applicable" due to the nature of the document.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative sense as might be expected for software or AI performance, but rather focuses on equivalence of physical/material properties and adherence to relevant standards.

Acceptance Criteria Category	Specific Criteria / Standard	Device Performance (Vatech Clismile)	Predicate Device (In-Ovation C)	Conclusion
Material Composition	Bracket (Body)	Polycrystalline Alumina (100%)	Polycrystalline Alumina (100%)	Same
	Door	Nickel-Cobalt Alloy (100%)	Nickel-Cobalt Alloy (100%)	Same
Transparency	Aesthetic property	Half-transparency	Half-transparency	Same
Bracket Design	ISO 27020:2010 compliance	MBT, ROTH designs with/without hook; Conforms to ISO 27020:2010	MBT, ROTH designs with/without hook; Conforms to ISO 27020:2010	Same
Self-ligating mechanism	Presence/Absence	Yes	Yes	Same
Orientation marking	Presence/Absence	Yes	Yes	Same
Packaging	Sterility	Non-sterile packaging	Non-sterile packaging	Same
Dimensions (In-out)	Range (mm)	1.05 to 1.54	1.05 to 1.55	Similar
Torque	Range (°)	-11 to +17	-11 to +17	Same
Angulation	Range (°)	0 to 13	0 to 13	Same
Slot Sizes	Available options	0.022 inch	0.018" / 0.022 inch	Similar
Dimensional Analysis	ISO 27020 & Comparison to Predicate	Dimensions confirmed to be the same within error range (for specific models)	-	Same within error range
Biocompatibility	ISO 10993-5 (cytotoxicity)	Evaluation report available	-	Met
	ISO 10993-10 (sensitization)	Evaluation report available	-	Met
	ISO 10993-11 (systemic toxicity)	Evaluation report available	-	Met
Material Safety	ISO 22674 (hazardous element & corrosion for metal cap)	Evaluation report available	-	Met

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Specific sample sizes are not explicitly stated for all tests. For "Dimensional analysis," specific models "Clismile 12-1223" and "IN-OVATION C H100-132-81" (corresponding to the maximum canine) were used for comparative assessment. The document states "Bracket generally uses a one-kit product consisting of 20 brackets." and that "Clismile is also composed of the same number of sets" as the predicate.
Data Provenance: Not specified, but the manufacturing company is Rayence Co., Ltd. from Gyeonggi-do, Korea. The tests are likely internal company evaluations or performed by accredited labs.
Retrospective/Prospective: Not specified, but given the context of a 510(k) submission, these would be controlled tests performed for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document does not describe a study involving expert readers or establishment of ground truth in a clinical assessment context. The evaluations are primarily engineering and materials performance tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. (No expert adjudication involved for this type of technical performance testing).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-powered device and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the tests performed is based on:

Engineering specifications and measurements (e.g., dimensions, torque, angulation).
Material composition analysis.
Standardized test methods (e.g., ISO 27020 for brackets, ISO 10993 series for biocompatibility, ISO 22674 for metallic materials).
Direct comparison to the predicate device's established characteristics.

8. The sample size for the training set

Not applicable. There is no AI/ML model for which a training set would be required.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML model.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 6, 2022

Rayence Co.,Ltd Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin St. Ste 610 Houston, Texas 77054

Re: K220689

Trade/Device Name: Vatech Clismile Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: February 28, 2022 Received: March 9, 2022

Dear Dave Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K220689

Device Name Vatech Clismile

Indications for Use (Describe)

Vatech Clismile is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K220689

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510k summary prepared: January 28th, 2022

Submitter's Name, address, telephone number, a contact person:

Submitter's Name :	Rayence Co., Ltd.
Submitter's Address:	14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea
Submitter's Telephone:	+82-31-8015-6459
Contact person:	Mr. Kee Dock Kim / RA Team Manager / +82-31-8015-6459
Official Correspondent:	Dave Kim (davekim@mtech-inc.net)
Address:	7505 Fannin St. Ste 610-V111, Houston, TX 77054
Telephone:	+713-467-2607

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

Trade/proprietary name	: Vatech Clismile
Common Name	: Orthodontic ceramic bracket
Regulation Number	: 21 CFR 872.5470
Regulation Name	: Bracket, Ceramic, Orthodontic
Regulatory Class	: Class II
Product Code	: NJM(Orthodontic plastic bracket)

Predicate Device :

Trade/Device Name	: In-Ovation C
Common Name	: Orthodontic ceramic bracket
510(k) Number	: K060837
Regulation Number	: 21 CFR 872.5470
Regulation Name	: Bracket, Ceramic, Orthodontic
Regulatory Class	: Class II
Product Code	: NJM

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2. Device Description

This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth.

3. Indication for use

Vatech Clismile is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

4. Summary of Design Control Risk management

Vatech Clismile orthodontic brackets were developed with the same structure, material / operation method, and purpose as In-Ovation C.

The risks and the hazardous impact of the device modification were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted.

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5. Summary of the technological characteristics of the device compared to the predicate device:

Vatech Clismile described in this 510(k) has the same indications for use and similar technical characteristics as its predicate devices, IN-OVATION C (K060837).

Characteristic	Proposed Device	Predicate Device	Similarity
Manufacturer	Rayence CO., LTD	DENTSPLY International	-
Product Name	Vatech Clismile	IN-OVATION C	-
Picture	Image: Vatech Clismile	Image: IN-OVATION C	Similar
510(k) number	K220689	K060837	-
Indications foruse	Vatech Clismile is indicated fororthodontic movement of naturalteeth, excluding mandibularbicuspid teeth.	In-Ovation C is indicated fororthodontic movement of naturalteeth, excluding mandibularbicuspid teeth.	Same
Materialcompositionof Bracket	Polycrystalline Alumina(100%)	Polycrystalline Alumina(100%)	Same
Materialcompositionof Door	Nikel-Cobalt Alloy(100%)	Nikel-Cobalt Alloy(100%)	Same
Transparency	Half-transparency	Half-transparency	Same
Bracket design	MBT, ROTH designs withand without hook,conforming to ISO27020:2010 Dentistry –Brackets and tube for Use inOrthodontics	MBT, ROTH designs withand without hook,conforming to ISO27020:2010 Dentistry –Brackets and tube for Use inOrthodontics	Same
Self-ligatingmechanism	Yes	Yes	Same
Orientationmarking	Yes	Yes	Same
Non-sterilepackaging	Yes	Yes	Same
In-out(mm)	1.05 to 1.54	1.05 to 1.55	Same
Torque(°)	-11 to +17	-11 to +17	Same
Angulation(°)	0 to 13	0 to 13	Same
slot sizes	0.022 inch	0.018" / 0.022 inch	Similar

Comparison table

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6. Summary of Performance Testing

IN-OVATION C and Vatech Clismile have the same composition and raw material of the components constituting the device, and the purpose and principle of operation of the calibration bracket are the same. Bracket generally uses a one-kit product consisting of 20 brackets. The K100-552-81 model of In-Ovation-C is composed of 16 ceramic and 4 metal brackets, and the Clismile is also composed of the same number of sets.

The ceramic bracket is composed of alumina (Body) and Ni-Co alloy (Cap, MP35N)

The design characteristics of the product were evaluated for seven items specified in ISO 27020, which is a bracket standard. As representative products, dimensional analysis of "Clismile 12-1223" and "IN-OVATION C H100-132-81" corresponding to the maximum canine was conducted, and it was confirmed that the dimensions were the same within the error range.

7. Summary for any testing and reference guidance:

Dimension evaluation of prescription of orthodontic bracket according to standard ISO27020 (Brackets and tubes for use in orthodontics)

Evaluation report on biological stability according to standard ISO10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization, ), ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Evaluation of hazardous element content and corrosion test for metal cap bracket parts according to standard ISO 22674(Metallic materials for fixed and removable restorations and appliances)

8. Conclusions:

In accordance with the performance outcomes. Vatech Clismile demonstrated equivalent performance compared to In-Ovation-C. Therefore, Rayence claims the substantial equivalency between the proposed device and predicate device in terms of safety and effectiveness.

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.